00:53 , Dec 31, 2016 |  BioCentury  |  Finance

Delivering takeouts

  BioCentury’s 25th annual Buyside View finds biotech investors focusing on mid-cap names with late-stage or marketed products that could become M&A targets. “The main theme playing at the moment is investors like us are looking more...
07:00 , Mar 28, 2016 |  BC Week In Review  |  Clinical News

Anthim obiltoxaximab regulatory update

FDA approved a BLA from Elusys for Anthim obiltoxaximab to treat inhalational anthrax in combination with antibacterial drugs and prevent inhalational anthrax when alternative therapies are not available or are inappropriate. Anthim was approved under...
01:11 , Mar 22, 2016 |  BC Extra  |  Company News

FDA approves Elusys' Anthim for inhalational anthrax

FDA approved Anthim obiltoxaximab from Elusys Therapeutics Inc. (Pine Brook, N.J.) to treat inhalational anthrax in combination with antibacterial drugs, and to prevent inhalational anthrax when alternative therapies are not available or are inappropriate. Anthim...
08:00 , Nov 16, 2015 |  BC Week In Review  |  Company News

Elusys, Department of Health and Human Services infectious news

Elusys said it received a $44.9 million order for investigational anthrax therapy Anthim obiltoxaximab from HHS’s Biomedical Advanced Research and Development Authority (BARDA) for the U.S. Strategic National Stockpile. A BLA for the liquid...
02:44 , Nov 13, 2015 |  BC Extra  |  Company News

Elusys gets $44.9M BARDA order

Elusys Therapeutics Inc. (Pine Brook, N.J.) said it received a $44.9 million order for investigational anthrax therapy Anthim obiltoxaximab from the Biomedical Advanced Research and Development Authority for the U.S. Strategic National Stockpile. A BLA...
07:00 , Jun 15, 2015 |  BC Week In Review  |  Clinical News

Anthim obiltoxaximab regulatory update

FDA accepted a BLA for Anthim obiltoxaximab from Elusys to treat and prevent inhalational anthrax. The PDUFA date is March 18, 2016. The high-affinity humanized mAb against the Bacillus anthracis protective antigen inhibits binding...
07:00 , Oct 13, 2014 |  BC Week In Review  |  Clinical News

Anthim obiltoxaximab: Phase III data

An open-label, U.S. Phase III trial in 40 healthy adult volunteers showed that the addition of ciprofloxacin to a single dose of 16 mg/kg IV obiltoxaximab led to no increase in the frequency of adverse...
07:00 , Oct 13, 2014 |  BC Week In Review  |  Clinical News

Anthim obiltoxaximab: Phase III data

A double-blind, placebo-controlled, U.S. Phase III trial in 70 healthy adult volunteers showed that repeat doses of 16 mg/kg IV obiltoxaximab on day 14 or day 120 did not increase the number of adverse events...
07:00 , Oct 13, 2014 |  BC Week In Review  |  Clinical News

Anthim obiltoxaximab: Phase III data

Elusys said data from a double-blind, placebo-controlled, U.S. Phase III trial in 280 healthy adult volunteers support the safety and tolerability of single 16 mg/kg dose of IV obiltoxaximab. The most common adverse events related...
08:00 , Feb 24, 2014 |  BC Week In Review  |  Clinical News

Anthim: Completed pivotal trial enrollment

Elusys completed enrollment of 70 adult volunteers in a double-blind, placebo-controlled, U.S. pivotal trial evaluating 16 mg/kg IV ETI-204 given on days 1 and 14 or days 1 and 120. The compound has Orphan Drug...